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Polymer Technology Systems, Inc. recalls PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole bloo
Recalled July 4, 2012 · FDA recall Z-1903-2012 · Polymer Technology Systems
Hazard
During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay. · FDA Class II
Units
1650 vials
Sold at
Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.
Description
During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay.
Product
PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample
Manufacturer(s)
Polymer Technology Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →